A Quality of Life Study in Patients With Migraines

Depression Clinical Trial

Official title:

Dysphoric-like Disorder of Epilepsy, Is It Unique?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00298805
• Other study ID #: 05.02.073
• Status: Terminated
• Phase: N/A
• First received: March 1, 2006
• Last updated: August 8, 2013
• Start date: January 2006
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy.

Description:

A form of depression known as dysphoric-like disorder is common in people with epilepsy, which may significantly affect the quality of life in these people, as shown in a previous study. However, it is unclear if this depressive disorder is unique to patients with epilepsy. In order to assess whether these symptoms are unique and idiosyncratic to the epilepsy population, in this multi-center study, these dysphoric depressive features will be contrasted to those seen in patients with other neurologic or psychiatric conditions. Migraine is selected as one of the comparison disorders because it shares with epilepsy characteristics of being a recurrent episodic central nervous system disorder, and our site will only enroll patients with migraine headaches.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: April 2013
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female 18 years of age or older

• Have the diagnosis of migraine

• Have had no change in migraine medication(s) 30 days prior to study

• Achieve a satisfactory score on the Wide Range Achievement Test 3 (WRAT3) test at the screening visit

• Capable of completing self-reporting questionnaires

• Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

• Presence of a clinically significant comorbidity of an unstable or progressive nature

• Presence of major depression

• Participation in an investigational drug study within the past 30 days

• Inability to communicate well with site study personnel

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Headache
• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United States	North Shore Long Island Jewish Health System	Great Neck	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	GlaxoSmithKline, Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphoric-like depressive characteristics in patient with epilepsy		N/A (cross-sectional study)	No